Minitouch 3.8 Era System (Minitouch System)
FDA premarket approval P230002 · decided 2023-07-28
Approval details
- PMA number
- P230002
- Trade name
- Minitouch 3.8 Era System (Minitouch System)
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Microcube, LLC
- Date received
- 2023-01-30
- Decision date
- 2023-07-28
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for the Minitouch 3.8 Era System (Minitouch System). This device is indicated for ablation of the endometrial lining of the uterus for the treatment of menorrhagia (heavy menstrual bleeding) due to benign causes in premenopausal women for whom childbearing is complete.
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